Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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No fault compensation is no answer
- Jeremy D Budd (7 September 2002)
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Let's Clear the Chaff
- Anil Sharma (9 September 2002)
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No fault compensation fallacy
- Anthony C Barton (9 September 2002)
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WHO SHOULD PAY WHEN THINGS GO WRONG?
- Jennifer A Smith (10 September 2002)
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An easier and fairer way
- George H Hall (11 September 2002)
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No easier way
- Jeremy D Budd (12 September 2002)
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Open Season on Third Generation Pills
- James S. Smeltzer, MD, FACOG (12 September 2002)
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Oral contraceptives, venous thromboembolism, and the courts
- Ronald D Mann (12 September 2002)
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Fisher quotation
- Jeffrey R Johnstone (15 September 2002)
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Clinical implications of ruling on third generation contraceptives
- Paul A O'Brien (1 October 2002)
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Re: Clinical implications of ruling on third generation contraceptives
- David Crook (4 October 2002)
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Jeremy D Budd, GP Principal Bridgwater TA6 5YB
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No fault compensation schemes are not the answer to disputes about whether a drug has caused damage. The issue of causation is just as problematical as in fault-based disputes. If the relative risk is less than 2.0, then on the balance of probabilities the damage was not caused by the medical treatment, but instead by natural causes. In my view the courts remain the best forum for complex disputes about causation to be aired, rather than in the bureaucratic procesess of a state Accident Compensation Scheme. While scientific consensus may not emerge from the courts, judges are the best qualified people to arbitrate on whether one point of view is better supported than another. Anyone who doubts this should read Lord Justice Stuart-Smiths superb judgement in Loveday v Renton and the Wellcome Foundation (3) [(the pertussis vaccine litigation) [1990] 1 Med LR 117] |
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Anil Sharma, Specialist Obstetrician and Gynaecologist Palmerston North, New Zealand
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Regarding the increased risk of venous thromboembolism secondary to the use of desogestrel, gestodene and more recently cyproterone containing COCP's; The answer is not judges and courts. How can an issue that has yet to be satisfactorily resolved by both impartial resesarchers and drug companies be hammered out over a few days by an individual who like myself has very limited understanding of Cox regression etc. Furthermore, it is hardly surprising that medical experts appear out of the woodwork for the benefit of mankind or indeed monetary gain, although more so that some evidence is ever accepted by the courts. The issue is fairly clear to me. Patients who were not appropriately counselled, (after prescribers were informed of the risks by their regulatory bodies)who then suffered injuries should be compensated. It is precisely because the clever doctors, statistician's and lawyers cannot decide upon the real truth that no fault compensation is crucial in the UK. regards, Anil Sharma |
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Anthony C Barton, solicitor and medical practitioner London EC1
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The suggestion that "consumers might receive fairer treatment from a system of no fault compensation" for injuries allegedly caused by by drugs is misconceived. The oral contraceptive pill litigation was advanced as a strict liability claim under the Consumer Protection At 1987; it concerned allegedly defective products rather than allegedly negligent conduct. Moreover, the court considered only the issue of causation. Consideration of fault was not relevant to the determination of this case. The pill case failed on causation. Systems of compensation for alleged drug induced injury include fault based (negligence) tort, strict liability under the Consumer Protection Act 1987, and limited no fault schemes (for example, the Vaccine Damage Payments Act 1979). All such schemes require proof of causation as a condition of compensation. The court has to make a decision that is just, certain and final. By contrast science is uncertain and often controversial; a "scientific consensus is unlikely to emerge", whether from the courts or the journals. Any judicial determination of causation based on probabilistic epidemiological evidence is at best approximate. However, it is preferable to the presumption 'post hoc ergo propter hoc' relied on by so many claimants and their lawyers. Professor Skegg rightly deplores the "futility" of the pill litigation; the case was, of course, brought by the claimants and funded largely at public expense. It represents yet another failed legally aided group action and accords with the near zero success rate of legally aided pharmaceutical claims against the industry. In the context of a collapsing health service, is this an appropriate use of public monies? Anthony Barton The author is employed as a legal consultant by CMS Cameron McKenna (solicitors), who acted for two of the defendants in the oral contraceptive pill litigation. |
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Jennifer A Smith, Surgical Research Trainee Gloucestershire Royal Hospital
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I t is intuitive to feel that a patient should receive some compensation when suffering an adverse outcome after medical care. A parent faced with the psychological and financial Everest of raising a disabled child after unexplained damage during labour and delivery deserves all the help they can get. But what about the self-employed builder with wound infection after an inguinal hernia repair? Apart from the arguments regarding the appropriateness of the current legal structure to settle medical claims, serious questions arise in determining compensation in a “no fault” setting. Most adverse outcomes result in some loss of earnings or quality of life, temporary or permanent. Who will decide whether more minor adverse events like surgical wound complications deserve pecuniary compensation? Is the NHS capable of funding the process and payments? In the fully informed and appropriately consented patient who suffers an adverse outcome, who should pay? |
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George H Hall, Retied physician Home EX1 2HW
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Part of the trouble is the curious cut off point of culpability- the mystical "balance of probability." This appears to mean that the adverse event is not "more likely than not" to have been due to the putative agent. Suppose 25 out of 100 have trouble with the old drug and 50 out of a 100 have trouble with the new drug. The relative risk is 2:1. The proportion of adverse events in those receiving the new drug and caused by it is 50%. So it's a toss up for each particular case whether the damage is due to the new drug or not. But this is obviously not the right answer or the right question. Half of those on the new drug having side effects have these because of the new drug. Fairness demands that any compensation due should be distributed equally as no one is sure who is suffering from the new drug. Therefore each person on the new drug with side effects should receive a half of the damages payable if it were known that they had suffered because of the new drug. Or is this too simple for both the statisticians and the judiciary? |
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Jeremy D Budd, GP Principal Bridgwater TA6 5YB
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Dr Hall's proposal would not work at all. To follow his logic, where the probability that a person's damage was caused by a drug or medical treatment was 10%, he would get 10% damages. Or 1% for a 1% risk. Such a system could lead to a monstrous explosion of claims for compensation. What Dr Hall, and Dr Jennifer A Smith, both ignore is that a patient who is informed that a treatment carries a certain risk, and elects to have it, also elects to run that risk in return for the benefits of treatment. The solution is for that person if he/ she wished, to insure against the possibility of ill health. The NHS can only spend each pound once. I am sure that Dr Hall would not feel liable to pay damages if he prescribed (for example) hormone replacement therapy, having informed the recipient that the risk of breast cancer would be increased by 25% after 10 years, to the (approximately) one in 100 if his patients that would be so affected. |
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James S. Smeltzer, MD, FACOG, Consultant, Maternal Fetal Medicine Wellstar Physicians Group, Marietta GA 30060
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To talk about economic and legal methods for making whole the loss of a life partner is to trivialize the issues of this debate. To have this "justice" hinge on whether or not third generation contraceptives kill 1.7 or 2.5 times as many women from pulmonary emboli than older and less profitable ones trivializes it to absurdity. Pharmaceutical companies, their officers and their minions within our own profession all act appropriately to maximize their profit. It is good business. If the courts are to help these corporations regulate their own behavior, then they must use a system of damages proportionate to the product of the monetized injury and the probability that the injury was caused by the drug, rather than the "reasonable degree of medical certainty" standard used. The fact that all of the corporate-funded studies come in below this standard, and most publicly funded studies meet the standard does raise to a high likelihood that the former studies are either deluded or fraudulent, or both. It is our mission to act with our prescribing pen in the best personal and fiducial interests of our patients and the health system. The fact that we continue to have our patients pay more for medicine that is more likely to kill them means that we are really not doing our job. Perhaps we are more appropriate targets for scorn. |
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Ronald D Mann, Professor Emeritus University of Southampton 42 Hazleton Way, Waterlooville, Hants PO8 9BT
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Editor – Professor David Skegg’s editorial(1) comment that “Consumers might receive fairer treatment from a system of no fault compensation” seems likely to secure considerable support. We must remember that the OC litigation before Mr Justice Mackay has not been the first vastly expensive and totally unhelpful action of this type in the High Courts this year. An earlier example(2) was the action in which Amanda Claire Smith unsuccessfully sued the Secretary of State for Health for terrible damage attributed to Reye’s syndrome. It seems likely that the legal teams on both sides received fees but the gravely and sadly damaged patient got nothing. Many of us professionally involved had our activities disrupted to no good cause whatever. The disruption caused by the OC litigation was far worse and the basis of the trial far more nonsensical. The legal principals for both sides agreed(3) that unless it could be shown that the true risk of venous thromboembolism with the third generation oral contraceptives was at least twice as great as with the third generation OCs compared with the second generation OCs then the action at law could not proceed beyond this point. This agreement ignored the facts that the value of delta in the Transnational study (the biggest relevant field study) was set at two or greater and that any difference of this order of magnitude would relate to the relevant categories of patients and not to individuals. Again, despite the number of weeks many of us spent on this trial, the legal teams were the only ones to have benefited. Certainly the injured patients didn’t. In 1989(4), in a joint conference with the Royal Society of Medicine, we published a paper on “No fault compensation – the BMA proposals” It is saddening that vast sums should be spent on actions of this type at law whilst the injured patients themselves gain nothing. It is time to revisit this issue and evolve a scheme (perhaps modelled on Swedish experience) which would aid patients and not fritter vast sums from which few but the lawyers gain. Ronald D Mann MD, FRCP, FRCGP, FFPM, Professor Emeritus, University
of Southampton.
References:- 1. Skegg, DCG. Editorial, BMJ 325, 504-505. 2. Mann, RD. A New medico-Legal Hazard to Pharmacoepidemiology. Pharmacoepidemiology and Drug Safety 2002; 11, Page S89 3. Mackay, The Honourable Mr Justice. Case Number 0002638, Approved Judgment; para 20, (1) 4. Bolt, D. No Fault Compensation – the BMA Proposals. In No Fault Compensation In Medicine (Editors Mann, RD & Havard, J.) London, Royal Society Of Medicine. 1989; 93-97 |
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Jeffrey R Johnstone, self-employed 7 Bruce St, Nedlands 6009, Western Australia
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The quotation from R.A. Fisher misrepresents him. His words in context carry a rather different meaning: "I do not relish the prospect of this science being now discredited by a catastrophic and conspicuous howler. For it will be as clear in retrospect, as it is now in logic, that the data so far do not warrant the conclusions based upon them." He had good reason to be concerned, as he says elsewhere: "It disproves at about the 1 per cent. level the hypothesis that inhalers and non-inhalers have the same cancer incidence. Even equality would be a fair knock-out for the theory that smoke in the lung causes cancer. The fact, however, and it is a fact that should have interested Hill and Doll in 1950, is that inhalers get fewer cancers, and that the difference is statistically significant." (p47) "And what makes it far more exasperating, when they put into effect an exceedingly important research, based on the habits of the medical profession, by asking about 60,000 doctors in Great Britain to register their smoking habits, and about 40,000 of them did so co-operatively, I am sorry to say that the question about inhaling was not in that questionnaire. I suppose the subject of inhaling had become distasteful to the research workers, and they just wanted to hear as little about inhaling as possible." (p20) Today Fisher might be yet more concerned. I think he might want to know why, in calculating deaths due to smoking, the results of biased rather than randomized sampling are used. And why the results of the only controlled trial of the efects of giving up smoking, the Whitehall study, have been consigned to oblivion and are never quoted. I think that today Fisher would despair at the misuse and debasement of the science he so loved. |
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Paul A O'Brien, SCMO Westside Contraceptive Services, Raymede Clinic, Exmoor St, London W10 6DZ
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What are clinicians to make of the judge’s ruling in the third generation oral contraceptive trial that the ‘most compelling evidence’ came from a novel and post-hoc reanalysis of data first published three years earlier? The judgement that there is no excess risk of venous thromboembolism with third generation pills rests on the acceptance of the validity of a single study sponsored by the manufacturers (1). Using epidemiological reverse engineering, data from a case-control study, which had found an increase in risk, were reanalysed using Cox regression technique as if they came from a prospective cohort (2). Centre stage was given to patients’, surely hazy, recollections of their pill use up to 20 years previously. Justice Mackay felt able to adjudicate on this very complex and unorthodox application of the Cox model, which has baffled epidemiologists, without the benefit of independent statistical advice. Skegg in his editorial called the judgement ‘bizarre’ (1). Clinicians who may interpret the judge’s ruling as allowing free prescription of third generation contraceptives could reconsider Iain Chalmers questions in bmj.com: What are the advantages to women of third generation oral contraceptives? Which outcomes, desired by women themselves, are more likely to be achieved with third generation than with second generation preparations? (3). These questions, which are best addressed by randomised controlled trials, have remained unanswered. When the excess risk with third generation contraceptives became known in 1995, doctors searched in vain for evidence to support their use by over one million women. The discrepancy between company-funded and independent epidemiology, which was commented on by the judge, has important implications for oral contraceptive research in general. Randomised trials of oral contraceptives are funded almost exclusively by the manufacturer for licensing purposes. As a number of new contraceptives are coming onto the market, complete transparency in reporting trials is essential. It is reassuring that the leading contraceptive journal has recently followed the example of top medical journals and endorsed the CONSORT guidelines on reporting of randomised trials (4). We await a similar endorsement from other journals in the field. Clinicians wishing to use third generation contraceptives should continue to heed the advice from the Medicines Control Agency. After reviewing all the data, including the controversial study, the Agency recommended that women should be informed of the small excess risk of venous thrombosis with third generation products (5). The excess risk is greatest for women starting the pill. 1. Skegg DC. Oral contraceptives, venous thromboembolism, and the courts. BMJ 2002;325(7363):504-5. 2. Lewis MA, MacRae KD, Kuhl-Habichl D, Bruppacher R, Heinemann LA, Spitzer WO. The differential risk of oral contraceptives: the impact of full exposure history. Hum Reprod 1999;14(6):1493-9. 3. Chamers I. What are the advantages to women of third generation oral contraceptives? http://bmj.com/ cgi/eletters/319/7213/795#4907 4 Grimes DA, Schulz KF. Randomized controlled trials in "Contraception": the need for "CONSORT" guidelines. Contraception 2001;64(3):139-42. 5. Medicines Commission. Combined oral contraceptives containing desogestrel or gestodene and the risk of venous thromboembolism. Current Problems in Pharmacovigilance 1999;25:12. Competing interests: I have consulted on prescribing practice for the claimants in the third generation contraceptive litigation. |
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David Crook, science writer Brighton UK
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In questioning whether there has ever been supportive evidence for the introduction of desogestrel, gestodene, and norgestimate as oral contraceptive (OC) progestogens, Paul O’Brien [1] ignores the issue of arterial disease. One rationale for the development of these steroids was a widespread belief during the 1970’s that further safety improvements could be made to OC beyond simply reducing the doses of steroids. Although the majority of OC users appeared to be content with existing formulations, there was a concern that progestogens such as levonorgestrel were too closely related to testosterone, the male hormone. An ideal progestogen was envisaged as one that displayed progestogenic but not androgenic activity. When combined with an estrogen, OC containing these new steroids were predicted not only to reduce the incidence of nuisance side-effects such as acne and hirsutism, but also to reduce the risk of OC-induced arterial diseases such as acute myocardial infarction (AMI) and stroke, both considered at that time to be linked to ‘maleness’. Whereas there was no consensus as to the mechanisms by which OC increased the risk of venous disease, their influence on classic determinants of arterial disease such as plasma lipoproteins, as well as emerging markers such as glucose and insulin metabolism, offered up a clear route to the development of ‘safer’ OC [2]. Against a background in the USA and elsewhere that arterial diseases in both sexes were eminently preventable, the metabolic profile of OC containing steroids such as desogestrel [3] was of obvious interest. The use of disease surrogates can and should be challenged: new markers are constantly emerging while at the same time the predictive value of established risk factors is under challenge. In this instance the role of arterial disease surrogates in directing OC reformulation is now supported by epidemiological evidence [4] that, as predicted, ‘third generation’ OC do not cause AMI. Competing interests: I have been consulted on the issue of arterial disease risk by the defendants in the third generation OC litigation. I was paid for that work. [1] O’Brien PA. Clinical implications of ruling on third generation contraceptives. eBMJ 1 October 2002 [2] Stadel BV. Oral contraceptives and cardiovascular disease. N Engl J Med 1981;305:612-18 [3] Godsland IF, Crook D, Simpson R et al. The effects of different formulations of oral contraceptive agents on lipid and carbohydrate metabolism. N Engl J Med 1990;323:1375-81 [4] Spitzer WO, Faith JM, MacRae KD. Myocardial infarction and third generation oral contraceptives: aggregation of recent studies. Hum Reprod 2002;17:2307-14 |
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